Trial Information

Since the first introduction of the GE Signa System by the Brigham and Women's Hospital as
the world's first intraoperative MRI in 1993, iMRI has been so increasingly applied that it
has been one of the most important techniques and concepts in the field of neurosurgery.
Many clinical studies have been reported on this respect, however, their evidence levels are
relatively not as good as what people hope they will be.Based on the available literature,
there is, at best, level 2B evidence that iMRI-guided surgery is more effective than
conventional neuronavigation-guided surgery.

Rationale: Intraoperative magnetic resonance imaging (MRI)-guided intracranial surgery, one
of whose most frequently reported indications is cerebral glioma surgery, may help update
images for navigational systems, providing data on the extent of resection and localization
of tumor remnants, and thereby enable intraoperative reliable immediate resection control to
eliminate the effect of brain shift on the extent of resection. Intraoperative MRI systems
can be divided into low-field intraoperative MRI(0.5T or less) and high-field intraoperative
MRI (1.5T or more) according to their various field strengths. The latter enables
intraoperative imaging at higher quality and more available imaging modalities but with more
cost and equipment requirements.

Purpose: We aim to do a single center prospective randomized triple-blind controlled
clinical trial to assess the effect of 3.0T high-field intraoperative MRI-guided glioma
resection on surgical efficiency and progression-free survival of malignant glioma. We
hypothesize that the use of high-field intraoperative MRI will enable more complete tumor
resection than conventional neuronavigation-guided resection,reducing the morbidity and
leading to more improved progression-free survival and quality of life in patients with
malignant glioma.

Morphology code of the International Classification of Diseases for Oncology (ICD-O)
{614A} and the Systematized Nomenclature of Medicine (http://snomen.org). Behaviour is
coded /0 for benign tumours, /3 for malignant tumours and /1 for borderline or uncertain
behaviour.

Tumor grade: grade II~IV according to the latest WHO grading criteria;

Appendix 2. Tumor location in eloquent areas:

located in or close to areas of the dominant-hemisphere that associated with motor or
language functions, including:

Study ID:

NCT ID:

Start Date:

Completion Date:

Related Keywords:

Name

Location

We are a Cancer Social Network, Resource Directory & Education Hub supporting all those affected by cancer. knowcancer.com is intended to be solely for informational purposes and should not be a substitute for professional medical advice, diagnosis or treatment.